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To Compare ZOLADEX 10.8 mg With ZOLADEX 3.6mg in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.

NCT03658213 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-05-10

No results posted yet for this study

Summary

This study will recruit 168 patients in approximately 20 study centres in China.

The primary objective of this study is to examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 24.

Conditions

Interventions

DRUG

ZOLADEX 10.8 mg

10.8 mg depot for injection (equivalent to 10.8 mg goserelin)

DRUG

ZOLADEX 3.6mg

3.6 mg depot for injection (equivalent to 3.6 mg goserelin)

Sponsors & Collaborators

Principal Investigators

  • Zefei JIANG · 307 Hospital of PLA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2021-11-04
Completion
2021-11-04

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658213 on ClinicalTrials.gov